Wright v. Medtronic, Inc.
81 F. Supp. 3d 600
W.D. Mich.2015Background
- This is a diversity products-liability action against Medtronic over the Infuse device (rhBMP-2) used in Plaintiff Wright's spine surgery; the device was implanted off-label in March 2010.
- Infuse was FDA-approved in 2002 for a single-level ALIF at L4-S1 with labeling cautioning anterior approaches and warning of potential ectopic bone formation; later FDA supplements expanded indications in some cases, but the core PMA labeling remained.
- Plaintiff alleges that Medtronic and its agents promoted off-label uses and trained surgeons to use Infuse with unapproved cages and posterior approaches, causing Plaintiff’s severe ongoing back and nerve pain and need for spinal stimulators.
- Plaintiff filed a five-count First Amended Complaint (Nov 21, 2013) asserting: Failure to Warn, Design Defect, Negligence, Fraud, and Breach of Express and Implied Warranties.
- Defendants moved to dismiss under Rule 12(b)(6) arguing express and implied preemption under the Medical Device Amendments (MDA) and independent grounds; the court applies Michigan law and rules on a preemption framework.
- The court grants the motion in part and denies in part: Counts I–III are dismissed as preempted; Count IV (Fraud) survives and Count V (Warranties) survives preemption but is dismissed for failure to plead a valid warranty claim; Plaintiff may file a Second Amended Complaint.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Express preemption of failure-to-warn claim | Wright argues FDA labeling does not preempt a parallel state claim for inadequate off-label warnings. | Medtronic contends the claim seeks state requirements that differ from or add to federal PMA labeling, thus express preemption. | Count I expressly preempted |
| Express preemption of design-defect claim | Design defect claims are grounded in state tort law and not limited to FDA labeling. | Design choices are regulated by FDA PMA; preemption applies to a design defect theory. | Count II express preemption; dismissed |
| Express/Implied preemption of negligence claim | Negligence based on off-label promotion is a state-law duty independent of the FDCA. | Promotional conduct collides with federal scheme; implied/express preemption applies. | Count III express and implied preemption; dismissed |
| Fraud claim and warranty claim post-preemption | Fraud and independent-state-law warranties can survive preemption if grounded in state law beyond FDCA. | Fraud may be non-preempted; warranty claims are constrained by labeling and disclaimer and lack privity. | Count IV survives; Count V survives preemption but is dismissed for failure to plead a cognizable warranty claim |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (explicit preemption framework for medical devices under MDA)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (FDCA preempts state-law fraud claims and sets limits on private enforcement)
- Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014) (off-label promotion and preemption analysis in FDCA context)
- Sprint Fidelis Leads Prod. Liab. Litig. (In re Medtronic Sprint Fidelis Leads), 623 F.3d 1200 (8th Cir. 2010) (design-defect preemption considerations in device litigation)
- Hawkins v. Medtronic, Inc., 62 F. Supp. 3d 1144 (E.D. Cal. 2014) (off-label promotion claims and preemption analysis under Buckman/FDCA)
- Houston I, 957 F. Supp. 2d 1166 (E.D. Cal. 2014) (off-label promotion and implied preemption discussions)
- Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206 (W.D. Okla. 2013) (design/marketing claims and preemption in Infuse context)